Maxsplit
EUDAMEDFDA UDIClass I (EU MDR)
Identity
- Trade Name
- Maxsplit EUDAMEDFDA UDI
- Generic Name
- Pill crusher/splitter FDA UDI
- Device Name
- Pill splitter EUDAMEDThe MAXSPLIT Pill Splitter with Puncher is crafted of quality and durable FDA compliant food grade plastic ensures that medications are contacting high quality, safe plastic and that the splitter is going to last over repeated use. When opening MAXSPLIT™, you will find an ergonomic U-shaped holder that allows pills of various sizes, shapes and thicknesses to be easily positioned and split safely and accurately. This U-shaped opening assists in proper pill alignment and the rubber insert holds pill in place while splitting to help ensure an accurate cut. FDA UDI
- Model / Reference
- C200 EUDAMEDBMS01R, BMS01B, BMS02R, BMS02B EUDAMEDBMS01R FDA UDI
- Description
- The MAXSPLIT Pill Splitter with Puncher is crafted of quality and durable FDA compliant food grade plastic ensures that medications are contacting high quality, safe plastic and that the splitter is going to last over repeated use. When opening MAXSPLIT™, you will find an ergonomic U-shaped holder that allows pills of various sizes, shapes and thicknesses to be easily positioned and split safely and accurately. This U-shaped opening assists in proper pill alignment and the rubber insert holds pill in place while splitting to help ensure an accurate cut. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00852359007168 EUDAMEDFDA UDI
- Basic UDI-DI
- 0852359007PS20YV EUDAMED
- FDA Product Code
- OHY FDA UDI
- EMDN Code
- V9099 VARIOUS DEVICES NOT INCLUDED IN OTHER CLASSES - OTHER EUDAMED
- GMDN Term
- Pill crusher/splitter FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 880.6430 FDA UDI
- Market of Registration
- France EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
No
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
No
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
Yes
Lot / Batch Number
No
Serial Number
No
Expiration Date
No
Manufacturing Date
No
Category: Device sterilization/disinfection container, reusable
Maxsplit by Maxpert Medical LLC. — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
CE/MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 0852359007PS20YV | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Maxpert Medical LLC.
- EUDAMED SRN
- US-MF-000035311
- Authorised Representative
- RIOMAVIX SOCIEDAD LIMITADA ES-AR-000001202
Sources (3)
- EUDAMED 6c153c20-bc63-4776-be10-088596167793 61 fields · synced Jul 19, 2026
- FDA UDI f11c43b3-ba63-41ac-a2fa-e1d2d604faed 33 fields · synced May 30, 2026
- EUDAMED 6c153c20-bc63-4776-be10-088596167793-1 61 fields · synced Jul 19, 2026